Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome

In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 110 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Hernia
• Intervention / Treatment: Procedure: Open Hernia surgery; Procedure: Robotic Hernia surgery

Detailed Description

Ventral hernias occur in up to 25% of the population. They are diverse in severity ranging from small umbilical hernias to large abdominal wall defects that may result in loss of domain. Approximately one-third are incisional hernias. Incisional hernias are usually more complex due to complications from previous surgery. The procedure may be complicated as a result of intraabdominal bowel adhesions and adhesions within the hernial sac. These factors cause discomfort and may complicate the repair. Ventral hernias may be repaired either through a minimally invasive laparoscopic procedure or an open approach. The laparoscopic repair was introduced in the 1990s and in 2003 the first robotic-assisted procedure was described in a porcine model. In 2012 the first series of robotic repairs were reported in humans. Due to the superior flexibility of the robotic instruments, there is a substantial interest in harnessing the advantages of the robotic platform. Because robotic repair differs in several technical aspects from the open approach, it is important to determine whether the short and long-term results differ between the two procedures. Furthermore, it remains unresolved whether the robotic procedure is able to provide comparable outcomes to the open repair when assessed for quality-of-life outcome measures. These questions are important to address in order to determine the most appropriate surgical options for individual patients.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian Als Nielsen; Phone Number: +45 79 97 00 00; Email: Kristian.Als.Nielsen3@rsyd.dk
• Study Contact Backup: Name: Michael Festersen Nielsen; Phone Number: +45 79 97 00 00; Email: Michael.Festersen.Nielsen@rsyd.dk

Study Locations

• Denmark
  • Southern Denmark
    • Aabenraa, Southern Denmark, Denmark, 6200
      • Recruiting
      • Sygehus Sønderjylland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age≥18
• ASA 1-3
• Clinical and radiologic diagnosis of primary midline ventral hernia
• Eligible to surgery according to a preoperative anaesthetic assessment
• Informed consent
• Able to understand written and oral Danish language

Exclusion Criteria:

• Incarcerated ventral hernia requiring emergency surgery
• Pregnancy
• Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
• Current cancer diagnosis
• Previous laparotomy
• History of psychiatric or addictive disorder that prevents the patient from participating in the trial
• Co-existing inflammatory disease
• Co-existing immunological disease that requires medication of any kind
• BMI >35 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open repair; Open ventral hernia repair	Procedure: Open Hernia surgery; primary midline ventral hernia repair - open
Experimental: Robotic-assisted repair; Robotic-assisted ventral hernia repair	Procedure: Robotic Hernia surgery; primary midline ventral hernia repair - robotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in satisfaction and quality of life	Satisfaction and quality of life were measured preoperatively at the outpatient clinic using the "abdominal hernia questionnaire" (AHQ) translated into Danish. The AHQ has 4 possible answers (All of the time, Most of the time, Some of the time, None the time OR Strongly disagree, Somewhat disagree, Somewhat agree, Strongly agree OR Very unsatisfied, Somewhat dissatisfied, Somewhat satisfied, Very satisfied)	From inclusion until 6 months after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time	Measured in minutes	Time from first incision to wound closure
Length of hospital stay	Length of hospital stay measured in days from admission to discharge.	From inclusion and until six months after surgery.
Change in Surgical stress response (CRP)	The degree of systemic inflammatory response expressed by C- reactive protein in serum	measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3.
Hernia defect size	Hernia defect size measured in mm either on CT scan or intraoperative.	Measured preoperatively
Intraoperative need of blood transfusion	The amount of blood transfused during surgery measured in mL	From first incision until last suture has been placed
Change in surgical stress response (Interleukins)	The degree of systemic inflammatory response expressed by cytokine levels in serum. All measurements will consist of weight/volume ratio (eg. CRP mg/L and IL-6 pg/mL)	Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3.
Treatment cost	Cost analysis of the two types of treatment	From inclusion until 6 months postoperatively

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Study Director: Michael Festersen Nielsen, Hospital of Southern Denmark - Aabenraa

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 15, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Ventral hernia; Robot; Da Vinci; Laparotomy; Hernia repair; Umbilical hernia; Epigastric hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: SHS-MT Kir-2-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No